Kornimate/medical-research-clean huggingface dataset:
interaction between vanoxerine (gbr 12909) and cocaine in cocaine dependent individuals

Conditions: Cocaine Abuse; Cocaine-Related Disorders

Summary: cocaine dependence is a major public health problem; an effective primary treatment for cocaine dependent individuals has yet to be found. the purpose of this study is to determine the safety and effects of vanoxerine (gbr 12909) in treating cocaine dependent individuals.

cocaine is a strong central nervous system stimulant that is widely abused throughout the united sates. due to its widespread use, it is important to develop an effective treatment for cocaine dependence. dopamine transporters (dat) play an important role in the addictive nature of cocaine; the use of compounds that target dat may be effective in treating cocaine dependent individuals. research shows that gbr 12909 has a strong affinity for dat. the purpose of this study is to determine the safety and potential interaction of gbr 12909 and cocaine in cocaine dependent individuals.

Eligibility criteria:
inclusion criteria: * meets dsm-iv criteria for current cocaine dependence * not currently seeking treatment for cocaine dependence * currently uses cocaine, as determined by a self-report and a positive urine test for cocaine, within 30 days prior to study entry * within 20 % of ideal body weight, and weighs at least 100 lbs * good general health * normal electrocardiogram * willing to use acceptable methods of contraception for the duration of the study exclusion criteria: * current or history of a major psychiatric illness, other than drug dependence or disorders secondary to drug abuse * meets dsm-iv criteria for dependence on any drugs other than cocaine, marijuana, nicotine, or alcohol * physiologically dependent on alcohol and requires medical detoxification * use of prescription drugs within 14 days prior to study entry * use of non-prescription drugs within 7 days prior to study entry * if female, used an oral contraceptive, depo-provera, norplant, or intrauterine progesterone contraceptive system, within 30 days prior to study entry * pregnant or breastfeeding * history of liver disease * current elevated aspartate aminotransferase or alanine aminotransferase levels * donated a unit of blood within 4 weeks prior to study entry * participated in any other clinical investigation within 4 weeks prior to study entry * history of any illness or behavior that, in the opinion of the investigator, might interfere with the study * family history of early significant cardiovascular disease * exhibits hepatitis b surface antigen or hepatitis c antibody * hiv infected * syphilis * active tuberculosis * adult asthma * chronic obstructive pulmonary disease * unable to distinguish between 20 mg and 40 mg of intravenous cocaine
a multicenter, randomized, double-blind, double-dummy study of azithromycin sr versus amoxicillin for the treatment of strep throat in children

Conditions: Tonsillitis

Summary: the objective was to determine if a single 60 mg/kg dose of azithromycin sr was as safe and effective as a 10-day regimen of amoxicillin (45 mg/kg/day, given in divided doses every 12 hours) when used to treat children with strep throat.


Eligibility criteria:
inclusion criteria: patients who had evidence of acute pharyngitis/tonsillitis based on erythematous pharyngeal mucosa or thick exudate covering the pharynx and tonsillar area, and at least one of the following signs or symptoms were included: sore/scratchy throat; pain on swallowing; chills and/or fever cervical adenopathy; scarlet fever rash on the face and skin folds, or red tongue with prominent papillae ("strawberry tongue"). subjects were required to have a positive rapid antigen detection test (radt) or a positive culture of the pharynx or tonsils for gabhs. exclusion criteria: patients were excluded if they had previously diagnosed disease(s) of immune function or treatment with any systemic antibiotic within the previous 7 days.
eptinezumab in real-world evidence: multicenter, real life, cohort study in migraine.

Conditions: Migraine Disorders

Summary: the object of this study is to assess the effectiveness, safety, and tolerability of eptinezumab in a real life migraine population.

eptinezumab is an humanized igg1 and the only anticgrp mab administered intravenously by a quarterly dosing regimen. in randomized-controlled studies (rcts), eptinezumab proved to be effective in preventing episodic and chronic migraine even in patients with 2 to 4 prior preventive failures and in shortening the time to complete migraine freedom when infused during a moderate-to severe migraine attack. eptinezumab 100 mg can be used for the first administration and later if deemed necessary, the dose upgraded to 300 mg. embrace is a multicenter, prospective, cohort, real-life study carried out in italian headache centers. consecutive patients with high frequency episodic (hfem: ≥8 migraine days/month) or cm (≥15 headache days/month), according to the international classification of headache disorders, 3rd edition (ichd-iii), referred to participating centers. the aim of this study is to assess effectiveness, safety and tolerability of eptinezumab 100 mg iv or 300 mg iv with a quarterly dosing regimen in a real-world migraine patients population.

Eligibility criteria:
key inclusion criteria 1. age between 18 and 75 years; 2. males and females; 3. willingness to sign the informed consent; 4. high frequency episodic migraine, at least 8 days per month of disabling migraine in the past 3 months; 5. chronic migraine, according to the ichd-iii criteria; key exclusion criteria 1. other headaches different than migraine; 2. known intolerance to eptinezumab or eccipients; 3. current treatment with other mabs; 4. vascular disease or raynaud.

Keywords: eptinezumab, calcitonin gene-related peptide, effectiveness, real-life, migraine, safety treatment
study on data acquisition and image characteristics of brain multifrequency eit in healthy people and patients with brain diseases

Conditions: Cerebral Hemorrhage; Cerebral Ischemia; Cerebral Edema; Healthy

Summary: the goal of this observational study is to compare the differences in the features of cerebral multifrequency eit(cmfeit) images between healthy subjects and patients with brain diseases and to explore the possibility of applying multifrequency eit to intracranial abnormality detection.16 healthy volunteers and 8 patients with brain diseases were recruited as experimental subjects, and the cerebral eit data of 9 frequencies in the range of 21 khz - 100 khz of all subjects were acquired with an eh-300 mfeit system.

for subjects who received clinical trials, 16 electrodes were placed equidistantly in their head, and brain eit data were measured at 9 frequencies in the range of 21 khz to 100 khz by applying a current rms of 176 microamps. the healthy group included 16 individuals (male, age 40.25±11.18). no history of brain disease and no abnormalities were seen on plain ct scans of their brains. cerebral eit data collection from healthy volunteers was performed in a dedicated laboratory with temperature controlled at 24±1 °c and 52%±1% humidity in 2022. the subjects were lying in a horizontal position. the patient group included 8 patients with brain diseases (7 males, age 59±10.46). obvious lesions were visible on the patients' ct or mri images, including 6 patients with intracranial hemorrhage, 1 patient with cerebral ischemia, and 1 patient with cerebral edema. data from patients with brain diseases were collected at the neurosurgical intensive care unit at the army medical center of pla in 2022. the cerebral eit data of the patients were collected in the same position as the healthy individuals. the mfeit image sequence is obtained according to a certain imaging algorithm, and the roi area ratio (ar_roi) on the left and right sides of the image and the average value of the reconstructed roi resistivity change (mvrrc_roi) are extracted. based on the extracted indicators, the geometric asymmetry index (gai) and intensity asymmetry index (iai) was further proposed to characterize the symmetry of mfeit images, and the differences between the two groups of subjects on mfeit images were statistically compared and analyzed.

Eligibility criteria:
inclusion criteria: 1. health group: no history of brain disease and no abnormalities were seen on plain ct scans of their brains. 2. patient group: patients with cerebral hemorrhage, cerebral ischemia, and cerebral edema, less than 12 days after onset. exclusion criteria: 1. health group: * neurological diseases such as epilepsy, brain tumors, and cerebral vascular malformations; * neurological symptoms such as headache and dizziness; * abnormal signals detected on ct. 2. patient group: * with other brain diseases without cerebral hemorrhage, cerebral ischemia, or brain edema; * with open craniocerebral injury; * with severe agitation.

Keywords: multifrequency electrical impedance tomography intracranial abnormality detection symmetry
diaphragmatic function in stroke patients.

Conditions: Paralytic Stroke; Cough

Summary: * this study attempts to elucidate whether stroke patients with dysphagia have reduced diaphragm movement during voluntary coughing, and also during deep inspiration and expiration than stroke patients without dysphagia. * this study will also compare various spirometric measurements with the diaphragmatic motions.

stroke is a debilitating condition that can impair multiple functions, including swallowing. stroke patients with dysphagia, are known to have reduced cough due to multiple mechanisms and this can impair their expectorate function. this can lead to accumulation of sputum and mucoid, ultimately resulting in aspiration pneumonia. stroke patients, especially those with dysphagia, are also known to have expiratory muscle weakness and weak cough than healthy controls. stroke patients are also known to have reduced diaphragm movement than healthy subjects. sonography is a useful tool that can easily and reliability measure diaphragm movement. whether stroke patients with dysphagia have reduced diaphragm movement than those without dysphagia and whether this affects voluntary cough have not been reported yet. this study attempts to evaluate diaphragm movements during voluntary cough in stroke patients with dysphagia and determine whether this reduced diaphragm movement correlates to their peak flow meters during voluntary cough.

Eligibility criteria:
inclusion criteria: * stroke patients with confirmed unilateral brain lesion * gross aspiration confirmed via fees or vfss that would require non oral feeding for group 1. * no gross evidence of dysphagia that would require non oral feeding for group 2. * no prior episode of stroke or dysphagia for the healthy control group. exclusion criteria: * episode of acute pneumonia or pulmonary embolism at time of enrollment * previous history of chronic respiratory disorders or other systemic disorders that may affect respiratory function ( ex, rheumatoid arthritis, chronic renal disease, spinal cord injury) * stroke patients with multiple brain lesions * episode of diaphragm weakness due to peripheral polyneuropathy or unilateral phrenic nerve palsy * previous episode of abdominal or thoracic surgery within one year of enrollment * concomitant diagnosis of myopathy, muscular dystrophy or other disorders that may affect respiratory muscles. * episode of rib fracture within one year of enrollment * chronic alcoholism * patient with previous diagnosis of dementia or with impaired cognitive function that may limit full participation at the evaluation.

Keywords: dysphagia,diaphragm, ultrasonography, inspiration, expiration,
multivalent hpv (human papillomavirus) vaccine study in 16- to 26-year old men and women (v503-003)

Conditions: Genital Warts; Anal Cancer; Anal Intraepithelial Neoplasia

Summary: this study is designed to evaluate the immunogenicity and tolerability of 9vhpv (9-valent hpv vaccine, v503) in 16- to 26-year old men and women. the overall goal is to bridge 9vhpv efficacy findings in young women to young men based on the demonstration of similar immunogenicity and safety profiles. the primary hypothesis is that 9vhpv induces antibody responses at 4 weeks postdose 3 in heterosexual males that are non-inferior to antibody responses in young women.

study participants will be administered a 3-dose regimen of 9vhpv. they will be assessed for immunogenicity 1 month following completion of vaccination. all participants will be followed for safety for a total of 12 months.

Eligibility criteria:
inclusion criteria: * good physical health * has never had papanicolaou testing (pap, cervical or anal) or has only had normal pap test results * other inclusion criteria will be discussed with the investigator exclusion criteria: * history of severe allergic reaction that required medical intervention * currently enrolled in a clinical trial * if participant is female, pregnant * currently immunocompromised or having received immunosuppressive therapy in the last year * positive test for hpv * history of hpv-related external genital lesions or hpv-related anal lesions or anal cancer * if participant is female, history of abnormal cervical biopsy results * other exclusion criteria will be discussed with the investigator
a study of adr-001 in patients with severe pneumonia caused by sars-cov-2 infection (covid-19)

Conditions: SARS-CoV-2 Infection( COVID-19 )

Summary: safety and efficacy of adr-001 are evaluated in patients with severe pneumonia caused by sars-cov-2 infection.

patients with severe pneumonia caused by sars-cov-2 infection are enrolled to the study. adipose-derived mesenchymal stem cells (ad-mscs) are administered once a week, total four times intravenously. safety and efficacy of ad-mscs are evaluated for 12 weeks after first administer.

Eligibility criteria:
inclusion criteria: * sars-cov-2 infection is confirmed on antigen test or pcr test * pulmonary infiltrative shadow is confirmed on chest x-ray test * pao2/fio2 \<=200mmhg at the time of screening exclusion criteria: * continue treatment for pneumonia before sars-cov-2 infection * sofa score \>= 15 * infection type on dic diagnosis criteria \>= 4 * deep venous thrombosis
open-label extension study to assess the long-term safety and tolerability of karxt in subjects with psychosis associated with alzheimer's disease (adept-3)

Conditions: Psychosis Associated With Alzheimer's Disease

Summary: this is a phase 3 global, multicenter, 52-week, open-label extension (ole) rollover study for subjects completing study cn012-0026, cn012-0027 or cn012-0056. subjects (randomized or non-randomized) who complete the 38-week cn012-0026 study, 14-week cn012-0027 study or 14-week cn012-0056 study will be eligible to enroll in cn012-0028. the primary objective of the study is to assess the long-term safety and tolerability of karxt in subjects with psychosis associated with alzheimer's disease.


Eligibility criteria:
key inclusion criteria: * must have completed study cn012-0026, cn012-0027 or cn012-0056. * subject was aged 55 to 90 years, inclusive, at the time of enrollment into the parent cn012-0026, cn012-0027 or cn012-0056 study. * can understand the nature of the study and protocol requirements and provide a signed informed consent or, if deemed not competent to provide informed consent, the subject's legally acceptable representative must provide informed consent, and the subject must provide informed assent before any study assessments are performed. * at entry into this study, or any time during the study, if a subject needs to relocate from home or residential assisted-living facility to a nursing home facility, the sponsor/medical monitor must approve the subject's participation in the study. * have an identified or proxy caregiver (spends approximately 10 hours/week with the subject). key exclusion criteria: * significant or severe medical conditions that, in the opinion of the investigator, could jeopardize the safety of the subject, ability to complete or comply with the study procedures or validity of the study results. * clinically significant abnormalities, including any finding(s) from the ecg, laboratory tests, physical examination, or vital signs, at the eot visit of study cn012-0026, cn012-0027 or cn012-0056 that the investigator, in consultation with the medical monitor, are considered to jeopardize the safety of the subject. * subjects participating in another investigational drug or device study or planning on participating in another clinical study during the duration of cn012-0028.
evaluate e1 wear, clinical performance of e1 liner in tha in korean patient population

Conditions: Osteoarthritis; Avascular Necrosis; Traumatic Arthritis; Rheumatoid Arthritis; Legg-perthes Disease

Summary: evaluate e1 wear, clinical performance of e1 liner in tha in korean patient population

total hip arthroplasty (tha) is one of the most successful surgical procedures in general. yet, a few problems remain unsolved, and aseptic loosening is probably the most important of them. one of the main reasons for aseptic loosening in tha is the foreign body reaction caused by the wear particles. since the late 1990s, the orthopedic industry has been developing highly crosslinked polyethylene (hxlpe) materials to capitalize on the increased wear resistance. in 2007, e1® antioxidant infused technology was developed to reduce wear rate, maintain mechanical properties and prevent oxidative degradation.

Eligibility criteria:
inclusion criteria: patients will be included in this study if they received ringloc acetabular system with e1 liner per the approved indications for use by kfda in korea. specifically, 1. osteoarthritis 2. avascular necrosis 3. legg perthes 4. rheumatoid arthritis 5. diastrophic variant 6. fracture of the pelvis 7. fused hip 8. slipped capital epiphysis 9. subcapital fractures 10. traumatic arthritis patients aged over 20 patients with limited co-morbidity - asa i - iii exclusion criteria: exclusion criteria for this study should comply with the stated contraindications on package inserts of ringloc acetabular system with e1 liner. these indications are stated below: absolute contraindications include: infection, sepsis, and osteomyelitis relative contraindications include: 1. uncooperative patient or patient with neurologic disorders who are incapable of following directions, 2. osteoporosis, 3. metabolic disorders which may impair bone formation, 4. osteomalacia, 5. distant foci of infections which may spread to the implant site, 6. rapid joint destruction, marked bone loss or bone resorption apparent on roentgenogram, and 7. vascular insufficiency, muscular atrophy, or neuromuscular disease. 8. pregnancy
von willebrand factor point-of-care testing to improve minimally invasive tavi outcomes

Conditions: Aortic Valve Stenosis; Aortic Valve Insufficiency

Summary: paravalvular regurgitation (pvr) is an important complication of transcatheter aortic valve implantation (tavi) that is associated with a 2.5-fold increase risk of mortality. transesophageal echocardiographic (tee) is considered as the gold standard to assess the severity of pvr and guide the physician to perform corrective procedures during tavi, but it requires general anesthesia (ga). with such approach (tee+ga), the partnerii trial has demonstrated that very low rate of pvr (3,5%) can be achieved with current devices. registries have demonstrated a strong trend for using a mini-invasive approach in which the procedure is performed under conscious sedation (cs) without tee. however, several studies raised concerns on the safety of this mini-invasive approach concerning the pvr rate. thus, the accurate and real-time assessment of the presence and severity of pvr is an unmet clinical need to optimize tavi without tee guidance. a recent study reported that a blood biomarker reflecting the von willebrand factor (vwf) activity, i.e. the closure time with adenosine diphosphate (ct-adp), is a valuable non-invasive, highly reproducible, and easy to perform alternative to tee for pvr evaluation. the hypothesis is that the measurement of ct-adp during tavi performed without tee guidance can improve both the detection of significant pvr and thus the procedural and clinical outcomes (primary objective).


Eligibility criteria:
inclusion criteria: * all patients scheduled to undergo mini-invasive tavi at any of the participating centers and fulfilling the inclusion criteria will be eligible for entry in the study. the decision to undertake tavi will be made by the local heart team. * symptomatic aortic stenosis scheduled to undergo tavi * tavi performed via mini-invasive approach defined as: transfemoral access route; local anesthesia/conscious sedation; no tee guidance. * all types of prosthetic valves (balloon-expandable, self-expandable, others) are accepted exclusion criteria: * tavi through non-transfemoral approach * tavi with concomitant percutaneous coronary intervention * tavi performed under general anesthesia * tavi performed under tee guidance * valve-in-valve procedure * inability to provide informed consent * associated ≥ moderate mitral regurgitation * peri-procedural treatment with ticagrelor or prasugrel treatment / direct oral anticoagulant

Keywords: transcatheter aortic valve replacement paravalvular regurgitation point-of-care test biomarker aortic stenosis von willebrand factor
study of assisted hatching of cleavage stage embryos

Conditions: Infertility

Summary: the purpose of this study was to determine if assisted embryo hatching can improve pregnancy rates for good prognosis patients undergoing in vitro fertilization (ivf) with day 3 embryo transfer.

assisted hatching is a procedure in which a hole is made in the hard covering of a developing embryo to allow the embryo to hatch more easily from this shell. this procedure is sometimes used before transferring embryos to patients after in vitro fertilization (ivf) in an attempt to improve resulting pregnancy rates. assisted hatching has been shown to improve outcomes among certain groups of patients, such as older patients or patients with a history of ivf treatment and embryo transfer without success. whether this procedure could benefit the broader patient population remains unclear. the purpose of this study was to evaluate potential benefits of assisted hatching for good prognosis patients who would not typically be treated with assisted hatching under current standard protocols. pregnancy rates were compared between good prognosis patients undergoing ivf with day-3 embryo transfer with or without assisted hatching of the transferred embryos.

Eligibility criteria:
inclusion criteria: * ivf patients with day 3 embryo transfer * maximum age of 39 years * maximum fsh 9 miu/ml * maximum e2 75 pg/ml * ovulatory menstrual cycles * good embryo quality exclusion criteria: * diagnosis of diminished ovarian reserve, polycystic ovarian syndrome, uterine or egg factor infertility * more than one previous unsuccessful ivf cycle

Keywords: assisted hatching cleavage stage, ovum embryo transfer pregnancy embryo implantation
vagifem low dose for postmenopausal atrophic vaginitis symptoms

Conditions: Menopause; Postmenopausal Vaginal Atrophy

Summary: this trial is conducted in north america. the purpose of this study is to determine if vagifem low dose is an effective and safe treatment for patients suffering from postmenopausal atrophic vaginitis.


Eligibility criteria:
inclusion criteria: * postmenopausal women whose last menstruation was at least two years previously